Targeting the Hippo Transducer TAZ in Breast Cancer With Statins

NCT02416427 | Unknown Phase 2

• 1 other identifier: 637/15
• Study Type: interventional
• Target: 78
• Locations: 0 countries
• Sites: N/A

Brief Summary

This pre-surgical, window-of-opportunity study is designed to investigate whether atorvastatin reduces the proliferation marker Ki-67 via modulation of the Hippo transducer TAZ.

Conditions

Breast Neoplasms

Keywords

Atorvastatin; TAZ; Hippo pathway; ki67

Outcome Measures

Primary Outcomes (1)

• Ki-67 reduction below the 15% (marker response).

  4 weeks

Secondary Outcomes (2)

• • Decreased TAZ expression

  4 weeks

• Pathway inhibition

  4 weeks

Study Arms (2)

Arm A

EXPERIMENTAL

Atorvastatin 80 mg/day for 3 weeks

Drug: Atorvastatin

Arm B

NO INTERVENTION

Observation

Interventions

Atorvastatin DRUG

Atorvastatin will be administered at 80 mg/day for 3 weeks in the time window between diagnostic biopsy and curative surgery

Arm A

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Signed written informed consent
• Female aged \>18 years and \<75 years at the time of the enrolment
• Histologically confirmed Breast Cancer (BC) independently on the intrinsic subtype
• Stage I-IIa BC patients candidate for elective surgery
• BC expressing Ki-67 ≥ 15% and TAZ \> 10% in diagnostic core biopsies
• Adequate baseline organ function
• Negative pregnancy test

You may not qualify if:

• Previous systemic therapy including chemotherapy, hormone therapy and targeted agents
• Administration of an investigational drug prior to enrolment
• History of another malignancy, except for a history of completely resected non-melanoma skin cancer or successfully treated cervical in situ carcinoma
• Eastern Cooperative Oncology Group (ECOG) performance status ≥2
• Subjects who have current active hepatic or biliary disease (with exception of patients with Gilbert's syndrome and asymptomatic gallstones)
• Serious cardiac illness or medical conditions including but not confined to: history of documented congestive heart failure (CHF) or systolic dysfunction (LVEF \<50%); high-risk uncontrolled arrhythmias (ventricular tachycardia, high-grade AV-block, supraventricular arrhythmias which are not adequately controlled); angina pectoris requiring antianginal medication; clinically significant valvular heart disease; evidence of transmural infarction on ECG; poorly controlled hypertension (e.g. systolic \>180mm Hg or diastolic \>100mm Hg)
• Have a concurrent disease or condition that may interfere with study participation, or any serious medical disorder that would interfere with the subject's safety (for example, active or uncontrolled infection or any psychiatric condition prohibiting understanding or rendering of informed consent)
• Current or recent therapy with statins for hypercholesterolemia or other lipid-lowering drugs
• Current or recent therapy with glucose-lowering drugs for diabetes
• Current or recent therapy with strong CYP3A4 inhibitors (e.g., clarithromycin, HIV protease inhibitors, itraconazole) given potential interactions with atorvastatin
• Current or recent therapy with gemfibrozil or other fibrates given potential interactions with atorvastatin.
• Patients who are pregnant or breastfeeding

Sponsors & Collaborators

• Regina Elena Cancer Institute: lead

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Atorvastatin

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Pyrroles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heptanoic Acids; Fatty Acids; Lipids

Central Study Contacts

Marcello Maugeri Saccà, MD

CONTACT

+39065266; maugeri@ifo.it

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD

Study Record Dates

• First Submitted: April 2, 2015
• First Posted: April 15, 2015
• Study Start: May 1, 2015
• Primary Completion: December 1, 2016
• Study Completion: December 1, 2016
• Last Updated: April 15, 2015

Record last verified: 2015-04